... 'Effective in High Risk Angioplasty Patients' ...TORONTO Oct. 3 / Much controversy has developed over the...Drug-eluting stents were found to be most effective in reducing thene...Reporting in the October 4th issue of the prestigious New EnglandJour...

TORONTO, Oct. 3 /PRNewswire/ - Much controversy has developed over the
past year about the safety and potential complications of drug-eluting
heart stents, increasing the risk of possible fatal blood clots, even years
after an angioplasty procedure. However, a new Canadian study led by
investigators from Ontario's Institute for Clinical Evaluative Sciences
(ICES) and McMaster University's Program for Assessment of Technologies in
Health, tells a different story.

Drug-eluting stents were found to be most effective in reducing the
need for repeat angioplasty procedures or bypass surgery in angioplasty
patients at the 'highest risk' for a renarrowing of the artery around the
stent, without significantly increasing the rate of death or risk of heart
attack. Lead Author, ICES Sr. Scientist, Dr. Jack Tu says, "This is good
news, reassuring patients and cardiologists about the safety of
drug-eluting stents when used in appropriate individuals. Our results also
suggest physicians should be selective in using drug-eluting stents,
offering them to angioplasty patients who are at the highest risk for
repeat cardiac procedures."

Reporting in the October 4th issue of the prestigious New England
Journal of Medicine, the large Canadian study conducted at ICES, in
collaboration with cardiologists and researchers from Sunnybrook Health
Sciences Centre and the University of Toronto, looked at over 3,700 unique
matched pairs of Ontario patients who received drug-eluting stents (DES) or
more conventional bare metal stents (BMS) during angioplasty. Using data
from the Ontario Cardiac Care Network's (CCN) population-based angioplasty
registry, and accounting for differences in patient characteristics,
investigators analyzed the outcomes of patients having angioplasty in
Ontario between December 2003 and March 2005 for the 'real-world'
effectiveness of DES. The results:

- DES reduced the need for a second procedure to unblock or bypass a

clogged artery by 30% relative to BMS, from 10.7% to 7.4%.

- After 3 years of follow up, mortality was reduced for DES patients

(5.5%) relative to BMS (7.8%).

- After 2 years of follow up, rate of heart attack for DES patients was

marginally but not significantly higher at 5.7% vs. 5.2% in BMS

patients.

- The reduction in the need for repeat procedures (i.e. target vessel

revascularization (TVR rate)) was greatest in patients with two or

three risk factors (e.g. diabetes, small vessels, or long lesions)

for renarrowing of the artery, whereas lower and intermediate risk

patients did not have significant reductions in TVR rates.

Co-Author, Dr. Eric Cohen, Medical Officer for CCN says, "Drug-eluting
stents have been at the centre of a very active worldwide debate regarding
issues of safety, degree of benefit and funding of a relatively expensive
new technology. This study will be very helpful to clinicians,
administrators and policy-makers in clarifying these issues as it confirms
that using drug-eluting stents in patients at high risk for renarrowing is
both effective and safe."

Interventional Cardiologists use the tiny wire mesh tubes called stents
to help prop open narrowed arteries after angioplasty, an artery clearing
operation and a common medical procedure for treating angina and heart
attacks. Prior to the development of stents, more than 20% of angioplasty
patients required a second angioplasty or bypass surgery because of
renarrowing of their coronary arteries. Both bare metal and drug-eluting
stents enable blood to flow more easily through the artery by holding it
open, with drug-eluting stents also leaking drugs to prevent tissue
re-growth from re-clogging the arteries.

ICES Sr. Scientist, Dr. Jack Tu who holds a Canada Research Chair in
Health Services Research at Sunnybrook Health Sciences Centre and the
University of Toronto, says, "Physicians implanting the devices need to
ensure patients who get a drug-eluting stent also take anti-clotting
medication such as aspirin and clopidogrel (antiplatelet therapy) for a
minimum of one year after the angioplasty procedure. This therapy reduces
the risk of fatal blood clots associated with drug-eluting stents. This
prolonged period of clopidogrel usage could explain differences between
results in Ontario, compared to those from other countries, such as Sweden.
In our study, these medications were made available to all elderly patients
in Ontario, at minimal cost, through the Ontario Drug Benefits Program for
one year after the angioplasty procedure."

Since their introduction in 2003, more than six million heart patients
worldwide have received a drug-eluting stent (DES). The DES market is worth
$5 billion a year, costing about $2300 for a DES versus $700 for a bare
metal stent (BMS). The rate of DES use in countries like the United States
was as high as 90% but dropped to about 70% in the past year, after recent
controversy over safety. Recent studies from Europe and Sweden suggest DES
may increase mortality and heart attack after a coronary angioplasty. The
rate of DES usage in Ontario was on average 38% of all stents during the
study period. In 2003, the Ontario government approved the introduction of
DES provincially, conditional upon an independent evaluation of their
effectiveness and cost-effectiveness. Approximately 20,000 angioplasties
are performed each year in the province of Ontario.

The study "Effectiveness and safety of drug-eluting stents in Ontario"
is in the October 4th issue of the New England Journal of Medicine. The
study was funded by operating grants from the Ontario Ministry of Health
and Long-term Care and a Canadian Institutes of Health Research Team Grant
in Cardiovascular Outcomes Research.

ICES is an independent, non-profit organization that uses
population-based health information to produce knowledge on a broad range
of health care issues. Our unbiased evidence provides measures of health
system performance, a clearer understanding of the shifting health care
needs of Ontarians, and a stimulus for discussion of practical solutions to
optimize scarce resources. ICES knowledge is highly regarded in Canada and
abroad, and is widely used by government, hospitals, planners, and
practitioners to make decisions about care delivery and to develop policy.

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